Decision to open access to atomoxetine and change funded brand

31 January 2019

Medicines Decision

There has been a delay, read the latest notification

10 January 2020 - Atomoxetine – delay in change of funded brand and open access

What we’re doing

We’re pleased to announce that all funding restrictions on atomoxetine will be removed from 1 July 2019. We will also be changing the funded brand of atomoxetine; Generic Partners’ brand will be listed from 1 July 2019; and, after a transition period the current brand Strattera will be delisted on 1 December 2019.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 10 December 2018.

There are no changes to the original proposal. We want to thank everyone who provided all their thoughtful feedback to this consultation, which has fed into this decision.

Who we think will be most interested

Patients with attention deficit hyperactivity disorder (ADHD)
Family and whānau of patients with ADHD, and ADHD support groups
Clinicians involved with ADHD treatment
Suppliers of atomoxetine or other ADHD treatments
DHBs, pharmacists, and wholesalers.

Detail about this decision

Removal of restrictions

On 1 July 2019, all funding restrictions on atomoxetine will be removed (regardless of which brand is prescribed). This means there will no longer be a Special Authority on atomoxetine, nor any Hospital Indication Restrictions.

Brand switch

The subsidised brand of atomoxetine will change from Strattera to Generic Partners.

The Generic Partners brand of atomoxetine will be listed from 1 July 2019, in both community and hospital, at the following prices:

Chemical and presentation	Brand	Pack Size	Subsidy and price (ex-man., ex. GST)
Atomoxetine cap 10 mg	Generic Partners	28	$18.41
Atomoxetine cap 18 mg	Generic Partners	28	$27.06
Atomoxetine cap 25 mg	Generic Partners	28	$29.22
Atomoxetine cap 40 mg	Generic Partners	28	$29.22
Atomoxetine cap 60 mg	Generic Partners	28	$46.51
Atomoxetine cap 80 mg	Generic Partners	28	$56.45
Atomoxetine cap 100 mg	Generic Partners	28	$58.48

While a confidential rebate applies to Strattera, there will be no rebate on Generic Partners’ brand.

From 1 July until 31 August 2019 both Strattera and the Generic Partners brands will be listed and fully funded

From 1 September 2019, the subsidy on the Strattera brand will be reduced. This means that the subsidy for Strattera in the community will be decreased to match the subsidy for the Generic Partners brand. It will be the decision of Strattera’s supplier (Eli Lilly) whether to lower its price to match the subsidy or to have a manufacturer’s surcharge.

From 1 September 2019, the Strattera brand will be delisted in the hospital Schedule (Section H) and from then until 30 June 2022, Generic Partners brand will be the only Hospital Supply Status brand of atomoxetine, in DHB hospitals (with a 1% DV limit).

On 1 December 2019, Strattera will be delisted from the community Schedule (Section B) and the Generic Partners brand will be the only funded brand of atomoxetine in the community until 30 June 2022.

A Brand Switch Fee will apply from 1 December 2019 to 1 March 2020. This would be provided to pharmacists to allow them to assist patients with the transition.

Implementation

Your feedback was welcome and has helped us to ensure implementation activities will be developed to respond to issues you raised during consultation. In particular, for prescribers from primary care unfamiliar with prescribing atomoxetine there will be PHARMAC information and educational information from other sources to support you to prescribe atomoxetine. When this is produced it will be available on our website.

Key implementation activities are highlighted in our responses to consultation feedback below.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Most consultation feedback was positive, supporting the opening of access and generally supporting the brand switch as long as there was proper support for patients and clinicians during the transition.

A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you, is below.

Theme	PHARMAC response
Harm could arise during a brand switch. Patients and clinicians should be supported through this, mainly through careful messaging and easily accessible information directed at patients, prescribers, and pharmacists.	Brand changes are difficult – we know this. We will provide information from a number of sources to reduce any challenges arising for people who are part of the change. In addition there will be: patient and prescriber information available to support all people through the change. a 5-month transition period to provide plenty of time to make the change a brand switch fee to support community pharmacists supporting people to change their brand of atomoxetine.
Strattera should be available where patient does better on Strattera than on Generic Partners’ atomoxetine.	We decided to supply Generic Partners’ atomoxetine in part because it has been approved by Medsafe. This means it has undergone bioequivalence testing to ensure its works in the same way as the original brand. Strattera is the reference product for Generic Partners’ atomoxetine capsules. Under PHARMAC’s Exceptional Circumstances Framework, a practitioner could apply to PHARMAC to access another brand of atomoxetine if their patient did not tolerate the funded brand.
Atomoxetine should be open listed earlier than 1 July 2019.	The price we pay for atomoxetine will go down on 1 July 2019. Once we have that price reduction, we can then widen patient access to atomoxetine.
Atomoxetine is not always an appropriate treatment, and prescribers may not be familiar with its titration. Removing restrictions could lead to prescriptions in patients who do not have a diagnosis from a specialist.	We will support prescribers unfamiliar with atomoxetine treatment with a range of information from different sources. This will likely include the PHARMAC website, PHARMAC seminars and education from service providers with whom we have contracts to provide education and information to primary care about funded medicines. We acknowledge that any clinician will be able to prescribe atomoxetine. As noted above we intend to provide support for prescribers regarding the management of ADHD. When this is produced it will be available on our website. We encourage all clinicians to ensure they only prescribe medicines they are informed about.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.